EP 3679927 A1 20200715 - A METHOD OF MANUFACTURING A PHARMACEUTICAL COMPOSITION COMPRISING NEFOPAM AND ACETAMINOPHEN, AND THE PHARMACEUTICAL COMPOSITION OBTAINED THEREBY
Title (en)
A METHOD OF MANUFACTURING A PHARMACEUTICAL COMPOSITION COMPRISING NEFOPAM AND ACETAMINOPHEN, AND THE PHARMACEUTICAL COMPOSITION OBTAINED THEREBY
Title (de)
VERFAHREN ZUR HERSTELLUNG EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG MIT NEFOPAM UND ACETAMINOPHEN UND DADURCH ERHALTENE PHARMAZEUTISCHE ZUSAMMENSETZUNG
Title (fr)
PROCÉDÉ DE FABRICATION D'UNE COMPOSITION PHARMACEUTIQUE COMPRENANT DU NÉFOPAM ET DE L'ACÉTAMINOPHÈNE ET COMPOSITION PHARMACEUTIQUE AINSI OBTENUE
Publication
Application
Priority
EP 19151604 A 20190114
Abstract (en)
The present invention relates to a method of preparing a pharmaceutical composition comprising acetaminophen and nefopam, and wherein the wherein the pH-value of the pharmaceutical composition is adjusted to be between 4.8 and 5.8, preferably around 5.2. When the pH-value of the pharmaceutical composition is adjusted to be between 4.8 and 5.8, a stable pharmaceutical composition is obtained which is substantial free from impurities, i.e. the degradation impurities from nefopam and acetaminophen is below the Limit of Detection (LOD) at accelerated aging tests.
IPC 8 full level
A61K 9/20 (2006.01); A61K 9/48 (2006.01); A61K 31/167 (2006.01); A61K 31/395 (2006.01); A61K 47/12 (2006.01)
CPC (source: EP)
A61K 9/2013 (2013.01); A61K 9/2077 (2013.01); A61K 9/4858 (2013.01); A61K 31/167 (2013.01); A61K 31/395 (2013.01); A61K 47/12 (2013.01)
Citation (applicant)
- GIRARD ET AL., SYSTEMATIC EVALUATION OF THE NEFOPAM-PARACETAMOL COMBINATION IN RODENT MODELS OF ANTINOCICEPTION, 2011
- HEEL ET AL.: "Nefopam: A review of its pharmacological properties and therapeutic efficacy", DRUGS, vol. 19, 1980, pages 249 - 67, XP009017634, DOI: doi:10.2165/00003495-198019040-00001
- FAIRBROTHER, J.E.: "Analytical Profiles of Drug Substances", vol. 3, 1974, ACADEMIC PRESS, article "Acetominophen", pages: 1 - 110
- KOSHY ET AL.: "Stability of aqueous solutions of N-acetylp-aminophenol", J. PHARM. SCI., vol. 50, 1961, pages 113 - 18, XP055174811, DOI: doi:10.1002/jps.2600500204
- NEMETH ET AL.: "Determination of paracetamol and its main impurity 4-aminophenol in analgesic preparations by micellar electrokinetic chromatography", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 47, 2008, pages 746 - 749, XP022713835, DOI: doi:10.1016/j.jpba.2008.03.003
Citation (search report)
- [Y] CN 105030765 A 20151111 - SHENYANG PHARMTECH PHARMACEUTICAL R & D LTD
- [A] CN 106137984 A 20161123 - SHANXI GUORUN PHARMACEUTICAL CO LTD
- [A] WO 2005060957 A1 20050707 - ARAKIS LTD [GB], et al
- [A] CN 102266563 A 20111207
- [Y] TROITZKY A ET AL: "Stabilité physicochimique et bactériologique d'associations d'antalgiques de classe I en solution", ANNALES FRANCAISES D'ANESTHESIE ET DE REANIMATION, MASSON, PARIS, FR, vol. 27, no. 10, 1 October 2008 (2008-10-01), pages 813 - 818, XP025632561, ISSN: 0750-7658, [retrieved on 20081018], DOI: 10.1016/J.ANNFAR.2008.08.001
- [A] K. THOMAS KOSHY ET AL: "Stability of aqueous solutions of N-Acetyl-p-aminophenol", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 50, no. 2, 1 February 1961 (1961-02-01), pages 113 - 118, XP055174811, ISSN: 0022-3549, DOI: 10.1002/jps.2600500204
- [A] TU Y H ET AL: "Nefopam hydrochloride degradation kinetics in solution", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 79, no. 1, 1 January 1990 (1990-01-01), pages 48 - 52, XP009514465
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
DOCDB simple family (application)
EP 19151604 A 20190114; EP 2020050664 W 20200113